Zovirax 800 mg Dispersible Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Aciclovir

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

J05AB; J05AB01

INN (International Name):

Aciclovir

Dosage:

800 milligram(s)

Pharmaceutical form:

Dispersible tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; aciclovir

Authorization status:

Not marketed

Authorization date:

1994-09-09

Patient Information leaflet

Reason for update: Type II C.1.4 Update to GDS 30 and Minor labelling
findings
Market: IE
Agency Approval date: TBA
Text date: 21/04/2020
Text Issue and Draft No.: Issue 3, Draft 1
_ _
(GSK LOGO)
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOVIRAX 800 MG DISPERSIBLE TABLETS
ACICLOVIR
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1
What Zovirax is and what it is used for
2
What you need to know before you take Zovirax
3
How to take Zovirax
4
Possible side effects
5
How to store Zovirax
6
Contents of the pack and other information
1 WHAT ZOVIRAX IS AND WHAT IT IS USED FOR
Zovirax 800 mg Dispersible Tablets (called ‘Zovirax’ in this
leaflet) contain a medicine called aciclovir.
This belongs to a group of medicines called antivirals. It works by
stopping the growth of viruses.
Zovirax 800 mg Dispersible Tablets can be used to:

treat chickenpox

treat shingles
, and when started right after the rash appears, it canhelp reduce the
nerve pain that
can exist after the shingles rash has cleared
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZOVIRAX
DO NOT USE ZOVIRAX IF:

you are allergic (hypersensitive) to aciclovir, valaciclovir or any of
the other ingredients (listed in
Section 6).
Do not have Zovirax if the above applies to you. If you are not sure,
check with your doctor or
pharmacist before taking Zovirax.
WARNINGS AND PRECAUTIONS
Check with your doctor or pharmacist before taking Zovirax if:

you have kidney problems

you are over 65 years of age

you are thirsty. You must make sure you drink

Summary of Product characteristics

Health Products Regulatory Authority
21 May 2021
CRN00CD8H
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zovirax 800 mg Dispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 800 mg aciclovir
Excipient(s) with known effect:
This product contains sodium as Sodim starch glycollate, see section
4.4.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Dispersible Tablets.
White, biconvex, elongated, film-coated tablet, impressed with 'GX
CG1' on one face and plain on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zovirax Dispersible tablets are indicated for the treatment of
Varicella infections (chicken-pox) and Herpes zoster (shingles).
Studies have shown that early treatment of shingles with Zovirax has a
beneficial effect on pain and can reduce the incidence
of post-herpetic neuralgia (zoster-associated pain).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE IN ADULTS:
For treatment of Varicella and Herpes zoster infections, 800 mg
Zovirax should be taken five times daily at approximately
four-hourly intervals, omitting the night time dose. Treatment should
continue for seven days.
In severely immune-compromised patients (e.g. after marrow transplant)
or in patients with impaired absorption from the gut,
consideration should be given to intravenous dosing.
Dosing should begin as early as possible after the start of an
infection. Treatment yields better results if initiated as soon as
possible after onset of the rash.
DOSAGE FOR INFANTS AND CHILDREN:-
For treatment of varicella infections in infants and children;
6 years and over: 800 mg Zovirax four times daily
2 - <6 years: 400 mg Zovirax four times daily
Under 2 years: 200 mg Zovirax four times daily
Dosing may be more accurately calculated as 20 mg Zovirax/kg
bodyweight (not to exceed 800 mg) four times daily. Treatment
should continue for five days.
No specific data are available on the treatment of Herpes zoster
infections in immune-competent children.
DOSAGE IN T